Regulation (EC) 258/97, on novel foods and novel food ingredients, is one of the main legal instruments to regulate innovation in the area of food in the European Union.
Novel food refers to all foods which were not consumed in the EU to a significant degree before May 1997, i.e. before the current Regulation entered into force and in particular to food produced using new techniques and technologies, such as nanomaterials.
To market a novel food or ingredient, companies must apply to a EU country authority for authorisation, presenting the scientific information and safety assessment report. A marketing authorisation will cover conditions of use, designation of novel food or novel food ingredient, and specification and labelling requirements.
Alternatively, a novel food or ingredient may be marketed through a simplified procedure called "notification". The European Commission prepared an information guidance to assist businesses when a product does not require authorisation.
A Novel Food Catalogue has also been developed, listing products of plant and animal origin and other substances subject to the Novel Food Regulation. The list is non-exhaustive, and serves as orientation on whether a product will need authorisation under the Novel Food Regulation.